MAUDE Adverse Event Report: LABORIE MEDICAL TECHNOLOGIES CANADA ULC LABORIE T-DOC-7FD; DEVICE, CYSTOMETRIC, HYDRAULIC

Model Number T-DOC-7FD

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2019

Event Type  malfunction  

Event Description

Urinary catheter was inserted into patient's bladder and connected to computer via bluetooth device.Sensor readings were incorrect during calibration so catheter was replaced.The second catheter worked well.

• Brand Name: LABORIE T-DOC-7FD
• Type of Device: DEVICE, CYSTOMETRIC, HYDRAULIC
• Manufacturer (Section D): LABORIE MEDICAL TECHNOLOGIES CANADA ULC; unisensor usa, inc.; 112 corporate dr ste 12; portsmouth NH 03801
• MDR Report Key: 8662250
• MDR Text Key: 146814316
• Report Number: 8662250
• Device Sequence Number: 1
• Product Code: FEN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: T-DOC-7FD
• Device Lot Number: 181680
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1